Prescription medicine

Azelastine and fluticasone Brand names: Dymista

Azelastine and fluticasone (Dymista) is a prescription medicine with an FDA approval on record since 2012. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $2.02 per gram (Azelastin-flutic 137-50 mcg spr) in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the azelastine and fluticasone FDA label on DailyMed (effective December 15, 2024, Mylan Pharmaceuticals Inc.); the NDA 202236 record on Drugs@FDA; every azelastine and fluticasone label on DailyMed.

Highlights of the record

FDA label of December 15, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
Azelastine hydrochloride and fluticasone propionate nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older.

Forms and strengths

Spray (metered).

On the market

Earliest approval on file: May 1, 2012 Dymista, Mylan Speciality Lp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 3 first April 28, 2017; 3 with a marketed status in Drugs@FDA
Labelers listed (NDC): 6 of which 4 under generic applications, 1 under brand applications, repackagers included
Last listed patent: August 24, 2026 Dymista spray; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $2.02 per gram Azelastin-flutic 137-50 mcg spr
Shortage (FDA): No current entry
Recalls by its makers (FDA): 2 since 2018 0 Class I among all firms' recalls; latest February 1, 2019
FAERS reports: 4,071 through July 30, 2026

What is azelastine and fluticasone used for?

From the label: indications and usage
Azelastine hydrochloride and fluticasone propionate nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. Azelastine hydrochloride and fluticasone propionate nasal spray contains an H 1 -receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older.

Conditions named in the indications of azelastine and fluticasone's FDA labels, with every medicine labeled for each:

Allergies

FDA pharmacologic class: Corticosteroid and Histamine-1 Receptor Antagonist.

Source: FDA drug label (Azelastine Hydrochloride and Fluticasone Propionate), Mylan Pharmaceuticals Inc., effective December 15, 2024 (SPL set 7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e), via openFDA; the full label on DailyMed

What does the patient leaflet for azelastine and fluticasone say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid while using azelastine hydrochloride and fluticasone propionate nasal spray?
Azelastine hydrochloride and fluticasone propionate nasal spray can cause sleepiness or drowsiness. Do not drive, operate machinery, or do anything that needs you to be alert until you know how azelastine hydrochloride and fluticasone propionate nasal spray affects you. • Do not drink alcohol or take any other medicines that may cause you to feel sleepy while using azelastine hydrochloride and fluticasone propionate nasal spray. It can increase your chances of having serious side effects.

From the patient leaflet: How should I store azelastine hydrochloride and fluticasone propionate nasal spray?
Store azelastine hydrochloride and fluticasone propionate nasal spray upright with the dust cap in place at room temperature between 68°F to 77°F (20°C to 25°C). • Do not freeze or refrigerate azelastine hydrochloride and fluticasone propionate nasal spray. • Protect azelastine hydrochloride and fluticasone propionate nasal spray from light. • Do not use azelastine hydrochloride and fluticasone propionate nasal spray after the expiration date “EXP” printed on the bottle label and carton. • Throw away your azelastine hydrochloride and fluticasone propionate nasal spray bottle after using 120 sprays after initial priming. Even though the bottle may not be completely empty, you may not get the correct dose of medicine if you continue to use it. Keep azelastine hydrochloride and fluticasone propionate nasal spray and all medicines out of reach of children.

Is there a generic for azelastine and fluticasone (Dymista)?

The FDA approved the first generic azelastine and fluticasone on April 28, 2017. 3 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists azelastine and fluticasone from 4 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists 1 patent for Dymista spray, the last expiring on August 24, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2012 earliest approval on file
2017 first generic approved
2026 last listed patent
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for azelastine and fluticasone (Dymista)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.02 per gram (Azelastin-flutic 137-50 mcg spr), down 37% from $3.19 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Azelastin-flutic 137-50 mcg spr (generic)
Dymista nasal spray (brand)

$9.18

$2.02

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Azelastin-flutic 137-50 mcg spr	Generic	$2.02 per gram	n/a	-37%
Dymista nasal spray	Brand	$9.14 per gram	n/a	-0.4%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has azelastine and fluticasone been recalled?

The FDA's Enforcement Report lists 2 recalls naming azelastine and fluticasone since 2018: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
February 1, 2019	Class II	Mylan Pharmaceuticals Inc.	Defective Container: Potential for broken glass in the neck area of the glass bottles.
July 25, 2018	Class II	Mylan Pharmaceuticals Inc.	Presence of foreign substance: Potential for glass in the neck area of the glass bottles.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the azelastine and fluticasone label say about other medicines?

The azelastine and fluticasone label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Ketoconazole	drug interactions	Other potent CYP3A4 inhibitors, such as ketoconazole: use caution with coadministration.
Ritonavir	drug interactions	Cytochrome P450 3A4 Ritonavir (a strong CYP3A4 inhibitor) significantly increased plasma fluticasone propionate exposure following administration of fluticasone propionate aqueous nasal spray, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology (12.3) ].

Check azelastine and fluticasone against other medicines

What do FAERS reports show for azelastine and fluticasone?

The FDA Adverse Event Reporting System holds 4,071 reports that list azelastine and fluticasone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 64 are coded as a death and 889 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Dyspnoea (named in the label)321
Drug Ineffective (a use or a product term, not a reaction)309
Fatigue (named in the label)284
Headache (named in the label)274
Asthma264
Cough (named in the label)253
Nausea (named in the label)237
Sinusitis204

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as azelastine and fluticasone?

6 other medicines are given the same way (nasal) and in the same FDA class as azelastine and fluticasone or labeled mainly for the same use (allergies), the same class first. Allergies lists all 36 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (nasal)	Pharmacy cost	Shortage
Triamcinolone	Allergies	24 labelers	$0.739 per mL 55 mcg nasal spr	Listed; available
Mometasone	Allergies	5 labelers	$1.59 per gram 50 mcg spry	No current entry
Budesonide	Allergies	5 labelers	$1.41 per mL 32 mcg nasal spray	No current entry
Olopatadine	Allergies	4 labelers	$0.850 per gram 665 mcg nasal spry	No current entry
Beclomethasone	Allergies	none listed	$30.23 per gram 80 mcg nasal spray	No current entry
Mometasone and olopatadine	Allergies	none listed	$7.67 per gram 665-25 mcg spray	No current entry

Every medicine labeled for the same conditions as azelastine and fluticasone

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to azelastine and fluticasone: 6 medicines for the same use
Other corticosteroids: the pharmacologic class, with prices and generics
Azelastine and fluticasone side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other